QUICKANCHOR ETHIBOND 212866Recalls & reported problems
Depuy Mitek, LLC · MICRO QUICKANCHOR Plus (Number 4/0) Suture 4/0 (1.5 metric) white ETHIBOND braided polyester suture, with C-1 taperpoint needles and a 1.3 x 5.0mm drill bit · Class 2 · Implant
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10886705002535), received between Jun 22, 2018 and Oct 26, 2023 — classified as 18 malfunctions.
The most frequently reported specific device problem is “Break” (9 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break9
- Device-Device Incompatibility3
- Migration or Expulsion of Device3
- Component Missing1
- Device Contamination with Body Fluid1
- Device Damaged Prior to Use1
- Device Reprocessing Problem1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- No Consequences Or Impact To Patient7
- Not Applicable1
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 26, 2023Device Reprocessing Problem; Material Fragmentation; Device Damaged Prior to Use; Device Reprocessing Problem; Material Fragmentation; Device Damaged Prior to Use
IT WAS REPORTED BY THE SALES REP THAT PRIOR TO A FINGER SURGERY ON (B)(6) 2023 THE MICRO QA+ #4/0 ETH C-1 DEVICE WAS FOUND BENT AT OPENING. DURING AN IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE INSERTER TIP WAS BROKEN AND THERE WAS FOREIGN MATTER ON IN THE ANCHOR. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18010454 ↗MalfunctionJan 23, 2023Break; Break
IT WAS REPORTED BY THE SALES REP IN SOUTH KOREA THAT DURING AN UNKNOWN PROCEDURE ON 12/30/2022, IT WAS OBSERVED THAT THE MICRO QUICKANCHOR PLUS PRELOADED WITH 4/0 ETHIBOND SUTURE AND C-1 NEEDLES DEVICE WAS CUT. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16224613 ↗MalfunctionNov 21, 2022Device Contamination with Body Fluid; Device-Device Incompatibility; Device Contamination with Body Fluid; Device-Device Incompatibility
IT WAS REPORTED BY THE CUSTOMER THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE MICRO QUICKANCHOR PLUS PRELOADED WITH 4/0 ETHIBOND SUTURE AND C-1 NEEDLES WOULD NOT LOAD WHEN THEY ATTEMPTED TO USE IT. DURING IN-HOUSE ENGINEERING EVALUATION, BIOLOGICAL MATTER COULD BE OBSERVED OVER THE ANCHOR, THE SUTURE AND SHAFT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15838282 ↗MalfunctionNov 13, 2022Device-Device Incompatibility; Device-Device Incompatibility
THIS IS REPORT 2 OF 2 FOR PC-(B)(4). IT WAS REPORTED BY THE SALES REP IN CANADA THAT DURING AN UNKNOWN SURGERY ON (B)(6)2022 , IT WAS OBSERVED THAT THE MICRO QUICKANCHOR PLUS PRELOADED WITH 4/0 ETHIBOND SUTURE AND C-1 NEEDLES DEVICE WOULD NOT RELEASE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15786174 ↗MalfunctionNov 13, 2022Break; Break
THIS IS REPORT 1 OF 2 FORPC-(B)(4). IT WAS REPORTED BY THE SALES REP IN CANADA THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022 , IT WAS OBSERVED THAT THE MICRO QUICKANCHOR PLUS PRELOADED WITH 4/0 ETHIBOND SUTURE AND C-1 NEEDLES DEVICE BROKE OFF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15786173 ↗MalfunctionAug 5, 2022Break; Break
IT WAS REPORTED BY THE SALES REP IN SOUTH KOREA THAT DURING AN UNKNOWN PROCEDURE OF THE HAND ON (B)(6) 2022, IT WAS OBSERVED THAT THE MICRO QUICKANCHOR PLUS PRELOADED WITH 4/0 ETHIBOND SUTURE AND C-1 NEEDLES DEVICE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15175714 ↗MalfunctionJan 12, 2022Break; Break
IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A HAND SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT BOTH THE ANCHOR AND SUTURE ON THE MICRO QA+ #4/0 ETH C-1 DEVICE BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13238009 ↗MalfunctionApr 13, 2021Misassembled During Installation; Misassembled During Installation
IT WAS REPORTED FROM THE AFFILIATE THAT THE MICRO QA SUTURE WOULD NOT LOAD IN THE ANCHOR. DURING AN IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE SHAFT INSERTER WAS BROKEN AND THE SILICON SLEEVE WAS FOUND DEFORMED IN THE DISTAL PART. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE PROCEDURE OR WHETHER A LIKE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11657102 ↗MalfunctionDec 17, 2020Break; Break
IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A HAND SURGERY PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE MICRO QA+ #4/0 ETH C-1 HAD BREAKAGE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE PROCEDURE, OR WHETHER A LIKE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11029634 ↗MalfunctionDec 17, 2020Break; Break
IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A HAND SURGERY PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE MICRO QA+ #4/0 ETH C-1 HAD BREAKAGE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE PROCEDURE OR WHETHER A LIKE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11029538 ↗MalfunctionJun 24, 2020Component Missing; Residue After Decontamination; Component Missing; Residue After Decontamination
IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, IT WAS OBSERVED THAT THE MICRO QA+ #4/0 ETH C-1 DID NOT WORK. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE ANCHOR, SUTURE, NEEDLES AND THE COVER WERE NOT RECEIVED IN THE PACKAGE TO BE EVALUATED AND THE DEVICE PRESENTED BIOLOGICAL RESIDUES. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. NEW ANCHORS WERE USED TO COMPLETE THE SURGERY SUCCESSFULLY. THERE WERE NO FRAGMENTS GENERATED. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10189658 ↗MalfunctionMay 11, 2020Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam
IT WAS REPORTED BY AFFILIATE VIA COMPLAINT SUBMISSION TOOL THE MICRO QA+ #4/0 ETH C-1. ¿SUTURES INSIDE DID NOT PULL OUT. HAD TO JIMMY OPEN THE TOP OF ¿SLIDING DOOR¿ TO GENTLY MANUALLY PULL OUT¿ NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE AVAILABILITY IS UNKNOWN.
Patient problems: Not Applicable
MAUDE report 10043820 ↗MalfunctionApr 28, 2020Break; Break
IT WAS REPORTED BY AFFILIATE VIA COMPLAINT SUBMISSION TOOL THAT DURING HAND SURGERY, MICRO QA+ #4/0 ETH C-1, THE PART THAT CONNECTED BETWEEN SUTURE AND SUTURE NEEDLE IS BROKEN. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE REPORTED THE EVENT OCCURRED DURING SUTURING OF THE PATIENT'S FINGER. IT WAS REPORTED AS SOON AS THE SURGEON WAS AWARE OF THE REPORTED ISSUE A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE AFFILIATE REPORTED PATIENT HARM OR DELAY DID NOT OCCUR.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10006827 ↗MalfunctionSep 18, 2018Break; Break
IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE ANCHOR DEVICE BROKE OFF FROM THE SETTING TOOL DURING IMPLANTATION. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7884662 ↗MalfunctionAug 31, 2018Migration or Expulsion of Device; Migration or Expulsion of Device
THE CUSTOMER REPORTED VIA PHONE THAT TWO OF THEIR MICRO QA+4-0 ETHBND (C1) W/1.3MM BIT WOULD NOT GRASP THE BONE DURING AN UNKNOWN PROCEDURE. THE CASE WAS COMPLETED USING ANOTHER LIKE DEVICE IN THE SAME BONE HOLE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE DEVICES ARE BEING RETURNED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7839258 ↗MalfunctionAug 18, 2018Migration or Expulsion of Device; Migration or Expulsion of Device
THE CUSTOMER REPORTED VIA PHONE THAT TWO OF THEIR MICRO QA+4-0 ETHBND (C1) W/1.3MM BIT WOULD NOT GRASP THE BONE DURING AN UNKNOWN PROCEDURE. THE CASE WAS COMPLETED USING ANOTHER LIKE DEVICE IN THE SAME BONE HOLE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE DEVICES ARE BEING RETURNED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7796088 ↗MalfunctionAug 18, 2018Migration or Expulsion of Device; Migration or Expulsion of Device
THE CUSTOMER REPORTED VIA PHONE THAT TWO OF THEIR MICRO QA+4-0 ETHBND (C1) W/1.3MM BIT WOULD NOT GRASP THE BONE DURING AN UNKNOWN PROCEDURE. THE CASE WAS COMPLETED USING ANOTHER LIKE DEVICE IN THE SAME BONE HOLE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE DEVICES ARE BEING RETURNED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7796087 ↗MalfunctionJun 22, 2018Break; Break
IT WAS REPORTED THAT THE NEEDLES BROKE OFF THE ANCHOR, THEY THEN ATTACHED A SPRING LOADED NEEDLE TO ATTACH TO THE TISSUE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7630663 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.